Abstract

DEVELOPMENT AND EVALUATION OF STABILITY INDICATING RP- HPLC METHOD FOR ANALYSIS OF BESIFLOXACIN IN PHARMACEUTICAL FORMULATION

Chhote Lal Singh*, Amit Singh, Santosh B M, V Ramesh Kumar, Panchkalyani *R. V. Northland Institute

Abstract

In the present work RP-high performance liquid chromatography (RPHPLC) method was developed and validated for the determination of besifloxacin in pure form and also in pharmaceutical formulations. The analyzed drug was separated on a reversed phase column with octadecyl silane (ODS-3) Inertsil® C18 column (250mm×4.6mm×5μm) by using a mobile phase containing 0.5% triethylamine (pH=3) and methanol- acetonitrile mixture (70:30 v/v) with UV detection at 289 nm. The calibration standards were prepared in the range of 0.05-20 μg/ml, where regression coefficient (r2) was found to be 0.999. The limit of detection and quantitation were 0.43 μg/ml and 1.29 μg/ml respectively. Results of proposed method were validated as per ICH guidelines. The stability studies included forced and non-forced degradation that was also performed to demonstrate the stability indicating power of developed method. Thus developed method was found to be simple, accurate, precise and robust to analyze the besifloxacin in different pharmaceutical formulations.

Keywords: Besifloxacin., RP-high performance liquid chromatography (RP-HPLC)., ICH- guidelines., Pharmaceutical formulations., Stability indicating validation., Force and non-force degradation.